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Completed

NCT Number: NCT03691948

Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

This is a randomized controlled pilot trial to establish methodological feasibility and determine whether a web-based, continuing dental education intervention regarding opioid prescribing risk mitigation strategies - consistent with ADA guidelines - produces pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental practice. The current study involves completion of a self-report pre-test (dentists), randomization to complete ROPEs or attention control intervention, completion of a self-report post-test (immediately following intervention/control completion), and completion of 1-month self-report follow-up assessment.

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Key information

Conditions

Knowledge, Attitudes, Practice Behavior

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jenna McCauley

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female; any race or ethnicity; age 21-85 years.
  • Able to comprehend English.
  • Be either a licensed dental practitioner currently practicing or a Resident enrolled in the College of Dental Medicine at the Medical University of South Carolina or a practicing dentist in the Charleston-county area or a licensed dental practitioner currently participating in the National Dental Practice Based Research Network (NDPBRN).
  • Report having ever prescribed an opioid analgesic to a patient
  • Must have Internet access
  • Must have a valid, usable email account
  • Must agree to complete all study measurements.

Exclusion criteria

  • Unable to provide informed consent due to mental or physical limitations.
  • Participation in ROPEs intervention development focus groups.

Treatment and study plan

Responsible Opioid Prescriber Education (ROPES)

Other

The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.

Active Comparator Control

Other

An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.

Primary outcomes

  1. Methodological Feasibility: Recruitment Rate

    Time frame: Baseline completion, approximately 2 hours

    Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.

  2. Methodological Feasibility: Completion Rates

    Time frame: Baseline completion, approximately 2 hours

    Percent of Patients Completing ROPES (or control)

  3. Methodological Feasibility: Follow-Up Completion Rates

    Time frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)

    Percent of baseline participants completing the one-month follow-up assessment

  4. Methodological Feasibility: Time to Complete Intervention

    Time frame: Baseline completion component, approximately 90 minutes

    Time participant takes to finish engaging with ROPES intervention or control intervention

Secondary outcomes

  1. Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score

    Time frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)

    The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge).

    This outcome will assess mean differences between groups in their change (from pre-test to one-month follow-up) in knowledge regarding best practices in dental opioid prescribing.

  2. Change at Post-test From Baseline in Knowledge Change Questionnaire Score

    Time frame: Single time point from pre-intervention to immediately post-intervention

    The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge).

    This outcome will assess mean differences between groups in their change (from pre-test to post-test) in knowledge regarding best practices in dental opioid prescribing.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Reducing Prescription Opioid Misuse: Dental Provider Intervention Development

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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